MedicalResearch.com: What is the background for this study? What are the main findings? What influence does medical marketing have on medical care and drug prices?

Response: There are published studies looking at promotional spending mostly for drugs (DTC and professional). This paper is unique because it is such a broad look including not just drugs but also marketing of disease (in “awareness campaigns”), health services and laboratory tests.

What is new here is the size and scope of marketing. For context, $29.9 billion spent on promoting prescription drugs, disease awareness campaigns, health services, and laboratory tests corresponds approximately to $1000 per American. For context, FDA’s total budget is around $5 billion – and NIH’s total budget is about $30 billion.

This figure is up from $17.7 billion in 1997, with the most rapid increase in DTC promotion of prescription drugs and health services. Pharmaceutical marketing to professionals (detailing visits and samples) accounted for most spending and remained high despite policies to limit industry influence.

$30 billion is of an underestimate (egg, we did not include monies spent on professional marketing (detailing) of laboratory tests, health services or devices, the value of drug coupons/discounts/rebates, company marketing budgets, lobbying or campaign contributions).

Further it is just the tip of the iceberg – marketing works so promotional spending is an important driver of why medical care is so expensive: it leads to more – and more expensive – tests and treatments.

Medical Research:What is the background for this study? What are the main findings?

Dr. Black: Lung cancer is the leading cause of cancer related death in the U.S., killing more people than cancers of the colon, breast, and prostate combined. In 2011, the National Lung Screening Trial (NLST) demonstrated that screening for lung cancer with low-dose CT could reduce lung cancer mortality by 20% in adults at high risk for the disease. Since then, several medical organizations have recommended that eligible adults be offered screening. The U.S. Preventive Services Task Force (USPSTF) released a grade B recommendation for low-dose CT screening in December 2012, which means that private insurers must cover the cost of screening by January 1, 2015. The Centers for Medicare and Medicaid (CMS) is expected to issue a final decision on national coverage for CT screening in February 2015 and a preliminary decision for public comment on November 10, 2014.

Naslund: In this study we explored whether people with severe mental illness such as schizophrenia, schizoaffective disorder, or bipolar disorder, use a popular social media website like YouTube to naturally provide and receive peer support. We found that people with severe mental illness use YouTube to feel less alone and to find hope, to support and to defend each other, and to share personal stories and strategies for coping with day-to-day challenges.

Dr. Grande: They also sought to learn from the experiences of others about using medications and seeking mental health care. YouTube appears to serve as a platform that helps these individuals to overcome fears associated with living with mental illness, and it also creates a sense of community among them. Continue reading →

Dr. Brinckerhoff: The genetic mutation BRAFV600E , frequently found in metastatic melanoma, not only secretes a protein that promotes the growth of melanoma tumor cells, but can also modify the network of normal cells around the tumor to support the disease’s progression. Targeting this mutation with Vemurafenib reduces this interaction, and suggests possible new treatment options for melanoma therapy.Continue reading →

Dr. Brown: Using simple team-based quality improvement methods we prevented kidney injury in 20% of patients having a procedure in the cardiac catheterization lab. Among patients with pre-existing kidney disease, we prevent kidney injury in 30% of patients.

We believed that using a team-based approach and having teams at different medical centers in northern New England learn from one-another to provide the best care possible for their patients. Some of the most innovative ideas came from these teams and identified simple solutions to protect patients from kidney injury from the contrast dye exposure; these included:

Getting patients to self-hydrate with water before the procedure (8 glasses of water before and after the procedure),

Allow patient to drink fluids up to 2-hours before the procedure (whereas before they were “NPO” for up to 12 hours and came in dehydrated),

Training the doctors to use less contrast in the procedure (which is good for the patient and saves the hospital money),

and creating stops in the system to delay a procedure if that patient had not received enough oral or IV fluids before the case (rather, they would delay the case until the patient received adequate fluids).Our success was really about hospital teams talking and innovating with one another instead of competing in the health care market, which resulted in simple, homegrown, easy to do solutions that improved patient safety.

Dr. Caller: We identified factors that appeared to increase the risk for a 30 day readmissions in the epilepsy population, which included refractory seizures but also coexistence of nonepileptic seizures and psychiatric comorbidities.Continue reading →

Dr. Thompson: This study, which surveyed 417 women aged 15-45 years and 188 contraceptive care providers in 2013, found important differences in what matters most to these two groups when it comes to discussing and deciding on a contraceptive method. Women’s most important question when choosing a contraceptive was “Is it safe?” – this was in the top three questions for 42% of women but only 21% of providers. Alternatively, providers’ most important question was “How is it used?”. Information on side effects and how a method actually works to prevent pregnancy was also a higher priority for women than for providers.Continue reading →

MedicalResearch.com Interview with: Gregory J. Tsongalis, PhD, HCLD, CC, FNACB
Professor of Pathology
Director, Molecular Pathology
Co-Director, Translational Research Program
Department of Pathology
Dartmouth Hitchcock Medical Center and
The Audrey and Theodor Geisel School of Medicine at Dartmouth Lebanon, NH 03756
MedicalResearch: What are the main findings of the study?

Dr. Tsongalis: This was the first study of its kind looking at multiple genes and multiple mutations in tumors of the appendix. Many of the identified mutations may be clinically actionable with respect to response to therapy or selection of therapy.

Dr. Bekelis:We demonstrated extensive regional and racial variation in the utilization of head CT scans in the first year after ischemic stroke. Increased use paralleled spending in corresponding Hospital Referral Regions. Greater fragmentation of care was associated with high intensity head CT utilization. African-Americans were associated with increased fragmentation of care and utilization of head CT.

MedicalResearch.com: Were any of the findings unexpected?

Dr. Bekelis:The extensive regional variation in the use of head CT for ischemic stroke has not been demonstrated before. In addition, the racial disparities in these practices are striking and are also reported for the first time. We identified that a major component of these utilization patterns is fragmentation of care, an issue not addressed previously through health care reforms. Hopefully the implementation of Accountable Care Organizations will minimize disparities and maximize continuity of care, with potential impacts in cost and overultilization.

MedicalResearch.com: What should clinicians and patients take away from your report?

Dr. Bekelis:We demonstrated that fragmentation of care is associated with overutilization of costly and potentially hazardous imaging modalities. From a physician’s perspective, every effort should be made to maintain continuity of care and enhance communication between providers in order to minimize this dangerous practice. Patients should avoid seeing multiple providers and be critical of unnecessary use of CT scans. Initiatives such as the “Choosing Wisely Campaign” can assist patients with decision-making.

MedicalResearch.com: What recommendations do you have for future research as a result of this study?

Dr. Bekelis:The best performing Hospital Referral Regions in terms of utilization and cost should be studied further. The particular practice patterns in these areas, and their methods of ensuring continuity of care should be identified. They can be used as examples that can be mirrored in order to maximize efficiency and minimize cost in the constantly changing health care landscape.

MedicalResearch.com Interview with James D. Sargent, MD, Professor of Pediatrics
Professor of Community and Family Medicine
Professor of The Dartmouth Institute
Co-Director, Cancer Control Research Program
Norris Cotton Cancer Center Norris Cotton Cancer Center,
Department of Pediatrics
Geisel School of Medicine at Dartmouth
Lebanon, New Hampshire

MedicalResearch.com: What are the main findings of the study?

Dr. Sargent: We showed children aged 3-7 years depictions of healthy foods in McDonald’s and Burger King television advertisements that aired in 2010-11. Children were asked what they saw in the images and not prompted to respond specifically to any aspect of the images. All images contained the two healthy foods—apples and milk—the companies purported to be advertising through the Children’s Food and Beverage Advertising Initiative. Only 52% and 70% of children correctly identified McDonald’s and Burger King images of milk. Whereas 80% correctly identified McDonald’s image of apples, only 10% identified the Burger King apples as apples. Instead, 81% mistook them as french fries.

Please see the video of children responding to the BK apples depiction at

Answer: When insurance coverage for young adults rose by over 15 percentage points following Massachusetts’ 2006 health reform, use of inpatient care for mental illness and substance use disorders fell and emergency department visits for these conditions grew more slowly for 19 to 25 year olds in Massachusetts relative to other states. Also, their care was much more likely to be paid for by private or public insurance insurers.

Answer:The study was able to illustrate the design and clinical testing of an MRI breast coil for combined MRI and Near Infrared Spectroscopy. The coil was tested on 8 healthy volunteers spanning all bra cup sizes and mammographic density categories. In the past, MRI/NIRS imaging was only possible in C and D cup sized breasts. The system also will give researchers the ability to target lesions in hard-to-reach areas close to the chest wall. With the successful completion of this study, simultaneous MRI/NIRS is possible in all breast sizes, tissue compositions, and lesion locations.Continue reading →

A large study of the daughters of women who had been given DES, the first synthetic form of estrogen, during pregnancy has found that exposure to the drug while in the womb (in utero) is associated with many reproductive problems and an increased risk of certain cancers and pre-cancerous conditions. The results of this analysis, conducted by researchers at the National Cancer Institute (NCI), part of the National Institutes of Health, and collaborators across the country, were published Oct. 6, 2011, in the New England Journal of Medicine.

Beginning in 1940, diethylstilbestrol, known as DES, was used clinically to prevent certain complications of pregnancy. In the 1950s, clinical studies showed DES was ineffective for this purpose. In the late 1960s, an unusual occurrence of a rare cancer of the vagina among young women, called clear cell adenocarcinoma (CCA), was observed and subsequently linked to their exposure to DES while in the womb.

In 1971, the U.S. Food and Drug Administration notified physicians that DES should not be prescribed to pregnant women. However, between 5 million and 10 million pregnant women and babies had been exposed to the drug. It was manufactured under many different product names, and came in various forms, including pills, creams and vaginal suppositories.

“Our study carefully documents elevated risk for DES-exposed daughters for a host of medical problems — many of them also quite common in the general population,” said study author Robert N. Hoover, M.D., director of the Epidemiology and Biostatistics Program in NCI’s Division of Cancer Epidemiology and Genetics. “Without the sentinel finding of a very rare cancer in young women, and without the sustained follow-up of those who were exposed, we would not know the full extent of harm caused by DES exposure in the womb.”

In this study, which included over 6,500 women (4,600 exposed and 1,900 unexposed), the researchers found that the daughters with exposure to DES while in the womb had an increased risk of 12 medical conditions, including a twofold higher risk of infertility and a fivefold increased risk of having a preterm delivery. (See table below for complete list of increased risks.)

This study is also the first to estimate the cumulative proportion of all DES-exposed women who developed these conditions because of their exposure. Of all DES-exposed women, 1 in 5 will experience some level of infertility because of their exposure. And of all those exposed women who are successful in having at least one birth, 1 in 3 will have a preterm delivery due to DES.

Although DES-exposed daughters have about 40 times the risk of developing CCA than unexposed women, CCA is still a rare disease, occurring in 1 in 1,000 DES-exposed daughters. While the first women diagnosed with this condition in the late 1960s were adolescents and young adults at the time of their diagnosis, the research now shows that the risk for DES-exposed daughters continues through at least age 40. In addition, these women are more than twice as likely to develop pre-cancerous cells in the cervix or vagina (called cervical intraepithelial neoplasia) and have an 80 percent higher chance of developing breast cancer after age 40. According to the results of this study, by age 55, 1 in 25 DES-exposed daughters will develop abnormal cellular changes in the cervix or vagina, and 1 in 50 will develop breast cancer due to their DES exposure.

This study was the first to assess risk based on the presence of vaginal epithelial changes as a biomarker of timing and dose of DES exposure. Exposed daughters with higher total dose of DES and younger age of the embryo at first exposure had evidence of these changes in the lining of the vagina. Women with these changes were at even greater risk for 9 of the 12 conditions compared to exposed women who did not have the biomarker.

This study did not evaluate sons with DES exposure in the womb, but previous reports have indicated an increased risk for certain testicular abnormalities, including undescended testicles or the development of cysts in the epididymis, tightly coiled tubes connected to the testicles. As DES-exposed sons grow older, more data will be available to assess their cancer risk. So far, research has shown no decreased fertility for these men, even with testicular abnormalities.

The women in this study were followed as part of the NCI’s DES Follow-up Study, which began in 1992. NCI researchers will continue to study DES-exposed daughters as they move into menopausal years. The cancer risks for exposed daughters, as well as sons, are continually being studied to determine if they differ from an unexposed population. In addition, researchers are studying possible health effects on the grandchildren of mothers who took DES during pregnancy, because some of the genetic changes caused by DES exposure in the womb may be inherited.

OAK BROOK, Ill. – July 25, 2011 – Researchers from New England report in a new study that using a tumor marker, serum CA 19-9, combined with an endoscopic ultrasound if the tumor marker is elevated, is more likely to detect stage 1 pancreatic cancer in a high-risk population than by using the standard means of detection. The study appears in the July issue of GIE: Gastrointestinal Endoscopy, the monthly peer-reviewed scientific journal of the American Society for Gastrointestinal Endoscopy (ASGE).

Pancreatic cancer is the fourth leading cause of cancer death in the United States. Advanced disease at diagnosis correlates directly with worse overall survival. Symptoms of abdominal pain, jaundice, and/or weight loss often do not appear until the tumor is locally advanced or metastatic, at which point effective treatment options are very limited. By contrast, detection and resection of pancreatic cancer, when it is confined to the pancreas (stage 1 disease), improves overall survival. An effective screening protocol is urgently needed to detect earlier stage tumors. Imaging methods that have been used for pancreatic cancer screening include endoscopic ultrasound (EUS), CT, endoscopic retrograde cholangiopancreatography (ERCP) and magnetic resonance imaging/MRCP.

There has been limited success in screening younger populations using the tumor marker CA19-9, so more recent pancreatic cancer screening protocols have focused on high-risk populations. It is estimated that 10 percent of patients in whom pancreatic cancer develops have at least one first-degree relative with the disease. Multiple cohort and case-control studies have demonstrated that a family history of a first-degree relative with pancreatic cancer significantly increases a patient’s risk of the development of pancreatic cancer, approximately two to five-fold. The risk of the development of pancreatic cancer increases significantly as the number of affected family members increases. Advanced age is also a significant risk factor, and 93 percent of patients with pancreatic cancer present after the age of 50.

“Our hypothesis was that a high-risk population identified by age and at least one first-degree relative with pancreatic cancer can be successfully screened. Our objective was to determine whether early pancreatic neoplasia can be detected in a high-risk population by using tumor marker CA 19-9 followed by targeted endoscopic ultrasound. We also sought to determine whether this protocol was more likely to detect early stage pancreatic cancer than standard means of detection,” said study lead author Richard Zubarik, MD, Fletcher Allen Health Care, University of Vermont. “Our results showed that potentially curative pancreatic adenocarcinoma can be identified with this screening protocol. Stage 1 pancreatic cancer is more likely to be detected by using this screening protocol than by using standard means of detection.”

Methods

This prospective cohort study was conducted at the University of Vermont (UVM) and the Dartmouth-Hitchcock Medical Center (DHMC). Patients were enrolled from September 2006 to July 2009. Patients included were between the ages of 50 and 80 and had at least one first-degree relative (parent, sibling, or child) with pancreatic cancer. Enrollment was initiated at age 45 if a patient had two first-degree relatives with pancreatic cancer and at age 40 if the person had a BRCA2 mutation or Peutz-Jeghers syndrome.

Serum CA 19-9 testing was performed on all patients. It was chosen as the initial screening method because it is acceptable to patients, easily obtainable, widely available, inexpensive, and relatively sensitive for the disease. Endoscopic ultrasound was performed only in patients with an elevated CA 19-9 level (a CA 19-9 value greater than 37 U/mL was considered elevated) regardless of whether only one or more than one family member was affected with pancreatic cancer.

Patients who were diagnosed with pancreatic cancer at UVM (but were not enrolled in the CA 19-9/EUS study) during the same period were prospectively identified and used as the comparison group. These patients were identified by the Cancer Data Registry at the University of Vermont. Charts were then reviewed to verify tumor type, staging data and survival.

Results

A total of 546 patients were enrolled in the study. CA 19-9 was elevated in 27 patients (4.9 percent). Neoplastic or malignant findings were detected in five patients (0.9 percent), and pancreatic cancer in one patient (0.2 percent). The patient with pancreatic cancer detected as part of this study was one of two patients presenting to the University of Vermont with stage 1 cancer. One-year follow-up contact was performed by telephone in 519 patients (95 percent), by chart review in 24 patients (four percent), and by review of the social security death index in three patients (less than one percent). Pancreatic cancer was not detected at the one-year follow-up in any additional patients.

In the comparison group, a total of 124 patients received a diagnosis of pancreatic cancer between September 2006 and July 2009. Staging of the comparison group at the time of presentation was as follows: stage 1, one patient (0.9 percent); stage 2, 52 patients (45.6 percent); stage 3, 20 patients (17.5 percent); stage 4, 41 patients (36 percent). The patient detected in the CA 19-9/EUS study had stage 1 disease, whereas only 0.9 percent of patients in the comparison group presented with stage 1 disease. This difference was statistically significant despite only having one patient with pancreatic cancer detected in the study group because the detection of stage 1 cancer in the comparison group was so rare. Median survival for the 122 subjects in the comparison group was seven months, with a 2-year survival rate of 10 percent.

The results conclude that potentially curative pancreatic cancer can be identified with CA 19-9 and targeted EUS. Stage 1 pancreatic cancer is more likely to be detected by using this screening protocol than by using standard means of detection. Potential advantages include acceptable rates of disease diagnosis and exclusion as well as acceptable costs (cost to detect 1 pancreatic neoplasia was $8,431, while the cost to detect 1 pancreatic cancer was $41,133). In particular, the patient with pancreatic cancer detected with this screening protocol is alive without evidence of recurrence three years after surgical resection and is the longest survivor of pancreatic cancer detected in a published screening protocol. Also, evidence of pancreatic cancer did not develop in subjects with negative screening studies, at least in short-term follow-up.

The researchers note that the sample size is adequate only to demonstrate the feasibility of this approach, but summarized that this trial successfully screened a high-risk patient population for pancreatic cancer based on age and genetic predisposition. Early pancreatic cancer, associated with prolonged disease-free survival, can be detected as part of this pancreatic screening protocol. Stage 1 pancreatic cancer was more likely to be detected with CA 19-9 and targeted EUS, and it appears to be superior to the standard means of pancreatic cancer detection.

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